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On March 9, 2020, FDA issued a new Constituent Update and FDA In Brief on the release of results from FDA’s sampling assignment with AMA Analytical Services, Inc. (AMA) testing talc-containing cosmetic products for the presence of asbestos.

On February 4, 2020, FDA held a public meeting on testing methods for asbestos in talc and cosmetic products containing talc.

On October 18, 2019, the FDA updated the Safety Alert and issued a new Constituent Update warning consumers not to use certain cosmetic products tested positive for asbestos.

The FDA continues to analyze cosmetics for asbestos contamination and will provide updates with additional information that becomes available.   

Talc is an ingredient used in many cosmetics, from baby powder to blush. From time to time, FDA has received questions about its safety and whether talc contains harmful contaminants, such as asbestos. 

FDA's Authority Over Cosmetic Safety

Under the Federal Food, Drug and Cosmetic Act (FD&C Act), cosmetic products and ingredients, with the exception of color additives, do not have to undergo FDA review or approval before they go on the market. Cosmetics must be properly labeled, and they must be safe for use by consumers under labeled or customary conditions of use. The law does not require cosmetic companies to share safety information with FDA. 

FDA monitors for potential safety problems with cosmetic products on the market and takes action when needed to protect public health. Before we can take such action against a cosmetic, we need sound scientific data to show that it is harmful under its intended use. Learn more about FDA's Authority Over Cosmetics.

Talc: What it is and How it is Used in Cosmetics

Talc is a naturally occurring mineral, mined from the earth, composed of magnesium, silicon, oxygen, and hydrogen. Chemically, talc is a hydrous magnesium silicate with a chemical formula of Mg3Si4O10(OH)2.

Talc has many uses in cosmetics and other personal care products. For example, it may be used to absorb moisture, to prevent caking, to make facial makeup opaque, or to improve the feel of a product.

Published scientific literature going back to the 1960s has suggested a possible association between the use of powders containing talc in the genital area and the incidence of ovarian cancer. However, these studies have not conclusively demonstrated such a link, or if such a link existed, what risk factors might be involved. The FDA has ongoing research in this area. In addition, questions about the potential contamination of talc with asbestos have been raised since the 1970s. 

Asbestos: What it is, Why it is a Concern, and How to Prevent its Occurrence in Cosmetics

Asbestos is also a naturally occurring silicate mineral, but with a different crystal structure. Both talc and asbestos are naturally occurring minerals that may be found in close proximity in the earth. Unlike talc, however, asbestos is a known carcinogen when inhaled. There is the potential for contamination of talc with asbestos and therefore, it is important to select talc mining sites carefully and take steps to test the ore sufficiently.

Public Meeting on Standards and Methods for Testing for Asbestos in Cosmetic Products Containing Talc

The FDA opened a public docket and held a public meeting on February 4, 2020, to discuss and obtain scientific data and information on topics related to cosmetic products with talc as an ingredient, specifically, testing methodologies, terminology, and criteria that could be applied to characterize and measure asbestos and other potentially harmful elongate mineral particles (EMPs) that may be present as contaminants in such products. The meeting included presentations by members of an interagency working group (the Interagency Working Group on Asbestos in Consumer Products or IWGACP).

The FDA made available, as part of the meeting materials, an Executive Summary titled “Preliminary Recommendations on Testing Methods for Asbestos in Talc and Consumer Products Containing Talc” by the IWGACP. Neither the Executive Summary nor any of the presentations at the public meeting by members of the IWGACP, represent proposed or preliminary recommendations or policies of the FDA or any other federal agency. The Executive Summary and related presentations at the public meeting were meant solely to solicit scientific feedback on the issues raised and should not be used for any other purpose.

The FDA and members of the IWGACP continue to evaluate the science and public feedback to the docket. The FDA does not have any recommendations at this time. Should the FDA decide to develop recommendations with respect to standards or testing methods for asbestos in talc, as a result of the information it received as part of the public meeting and comments to the public docket or otherwise, it would issue draft guidance for public comment.  Likewise, the FDA would propose any related regulations through a public notice and comment process.

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